CDSCO License for Percutaneous Long Term Intraspinal Catheter

Comprehensive Guide to CDSCO Licensing for Percutaneous Long Term Intraspinal Catheters (Class C Medical Device)

Navigating the regulatory landscape for high-risk medical devices in India can be challenging. With over 25 years of experience assisting 500+ companies, we provide you with a detailed, practical roadmap to obtain the CDSCO license for your Percutaneous Long Term Intraspinal Catheter, a Class C catheter device used for preimplant intra-spinal infusion screening trials.

Understanding the Device and Regulatory Importance

The Percutaneous Long Term Intraspinal Catheter is a critical medical device designed to conduct preimplant intra spinal infusion screening trial procedures before implanting a drug delivery pump. Given its invasive nature and high-risk classification (Class C), stringent regulatory oversight ensures patient safety and device efficacy.

This device falls under the Category: Catheters and is regulated under the CDSCO Notification No. 29/Misc/3/2017-DC (292) dated 06.06.2018. Compliance with CDSCO regulations is mandatory for manufacturers and importers aiming to market this device in India.

CDSCO Regulatory Framework for Percutaneous Long Term Intraspinal Catheters

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. For Class C devices like your catheter, the licensing process is centrally managed.

Key regulations include:

• Conformity assessment to Indian Medical Device Rules (IMDR) 2017
• Compliance with Essential Principles of Safety and Performance
• Submission of comprehensive technical documentation

Risk Classification and License Requirements

Your catheter is classified as Class C—a high-risk device requiring a thorough regulatory process.

Manufacturing License Process (MD9)

The manufacturing license for Class C devices involves several critical steps:

1. Test License (Form MD13): Initial test license is mandatory before product testing. This stage usually takes 1.5-2 months.
2. Product Testing: Testing must be conducted at CDSCO-approved laboratories to validate safety and performance. You can refer to the list of testing laboratories.
3. Document Preparation: Compile detailed documentation including Device Master File, Plant Master File, Risk Management File, and QMS documentation.
4. License Application (Form MD7): Submit the manufacturing license application for the MD9 license through the CDSCO MD Online Portal.
5. Audit and Inspection: CDSCO inspectors will audit your manufacturing premises and verify compliance.
6. Query Resolution: Address any queries or deficiencies raised during the audit.
7. License Grant: Upon satisfactory review, the license is granted on Form MD9.

For detailed guidance, our MD9 License Guide covers each step comprehensively.

Manufacturing License Documents Required

The documentation package must be thorough and precise, typically including:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Personnel Qualified per CDSCO requirements
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) containing manufacturing environment and equipment details (Plant Master File Guide)
• Essential Principles Checklist demonstrating conformity to safety standards
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, typically ISO 13485:2016 compliant

Import License Process (MD15)

If you are an importer of the Percutaneous Long Term Intraspinal Catheter, the import license falls under the MD15 category, issued by the Central Licensing Authority.

Key steps include:

1. Document preparation including manufacturing license, CE certificate, and Free Sale Certificate
2. Application submission on the CDSCO MD Online Portal
3. Query resolution with the department
4. Grant of the import license on Form MD15

Typical timeline: 5-6 months

Fees depend on risk class:

For more details, see our Import License Guide.

Import License Documents Required

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate from the competent authority
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license if applicable
• Company Constitution and other business registration documents

Timeline and Processing Duration

Total estimated duration: 4 to 5 months

Government Fees and Costs

• MD9 License: ₹50,000 per application + ₹1,000 per product
• Test License (MD13): Nominal fees as per CDSCO norms

Additional costs may include:

• Laboratory testing fees
• Audit fees charged by notified bodies
• Consultancy charges if outsourced

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved testing laboratories early; schedule tests ahead of application submission.

Challenge 2: Incomplete Documentation

• Solution: Use detailed checklists and consult experienced regulatory professionals to ensure completeness.

Challenge 3: Audit Non-compliance

• Solution: Prepare your manufacturing site with robust QMS, trained personnel, and documented procedures.

Challenge 4: Query Management

• Solution: Respond to CDSCO queries promptly and transparently, providing clear technical justifications.

Expert Consultation and Support

With decades of experience, our team specializes in navigating the complexities of CDSCO licensing for Class C medical devices like Percutaneous Long Term Intraspinal Catheters. We provide end-to-end support including:

• Pre-submission gap analysis
• Document preparation and review
• Coordination with notified bodies and testing labs
• Audit readiness and mock inspections
• Query management and follow-up

Getting Started with Your CDSCO License Application

1. Assess your device classification using resources like our Medical Device Classification.
2. Initiate the Test License (MD13) application on the CDSCO MD Online Portal.
3. Simultaneously, compile your Device Master File and Plant Master File.
4. Schedule product testing at CDSCO-approved labs.
5. Prepare your QMS and technical documents in alignment with CDSCO requirements.
6. Plan for the audit by selecting an appropriate notified body.

Starting early and following a systematic approach will streamline your pathway to market. Contact us for personalized assistance to ensure your Percutaneous Long Term Intraspinal Catheter meets all regulatory milestones efficiently and compliantly.